Comparison Between the I-gel and Protector Supraglottic Airway Devices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNikolopoulou Maria Zozefin
About this trial
This study aims to compare the learning curves of two different laryngeal mask airway devices, by evaluating their placement in adult patients performed by anesthesiology residents
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ASA I-II
Patients older than 18 years
Procedures in supine and lithotomy position
Disqualifiers
Tumors or anatomical anomalies of the upper airway
Known history of difficult intubation
Limited mouth opening less than 2cm
Decreased compliance of the lungs or the thoracic cage
Trial design
Design model
Parallel
Treatments tested in this trial
LMA Igel
Deviceadults allocated to the LMA Igel group, an LMA Igel device will be inserted intraoperatively
LMA Protector
Deviceadults allocated to the LMA Protector group, an LMA Protector device will be inserted intraoperatively
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: LMA Igel groupActive comparator 1 intervention
Group B: LMA Protector groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The time required for successful placement of the device
Time frame
Measured from the moment the clinician picks up the LMA device after induction of general anesthesia until the appearance of the first capnography waveform on the monitor with a maximum duration of 60 seconds per attempt and up to three attempts allowedSecondary outcomes
1
Documentation of adverse events during placement
Time frame
During the placement attemptSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nikolopoulou Maria Zozefin
Lead sponsor
Sismanoglio General Hospital
Sponsor institution
Source ClinicalTrials.gov